INFORMATION FOR PATIENTS An operation for stress incontinence - transobturator tape (TOT, TVT-O) We advise you to take your time to read this leaflet. If you have any questions please write them down on the sheet provided (towards the back) and we can discuss them with you at our next meeting. It is your right to know about the operations being proposed, why they are being proposed, what alternatives there are and what the risks are. These should be covered in this leaflet. This leaflet details what stress incontinence is, what alternatives are available within our Trust, the risks involved in surgery and what operation we can offer. The pressure in the abdomen rises when people cough, sneeze, turn or jump. This results in urine leakage. It can cause a lot of distress and can limit quality of life. It must be understood that these operations will not cure all urinary symptoms. They will only cure urinary symptoms caused by a weakness in the urethra (urine pipe) and bladder neck. Many urinary symptoms we see in clinic have other causes. Figure 1 Your anatomy - woman in upright position showing pressure above the bladder and a weak bladder neck. What is stress incontinence? Stress incontinence is the leakage of urine usually caused by an increase in pressure in the abdomen (tummy) such as when coughing or sneezing (see figure 1). This weakness is usually caused by childbirth in the first instance when the pelvic floor muscles and ligaments (attachments) are damaged. Further weakening occurs going through the menopause because the quality of the supporting tissues deteriorates.
Alternatives to surgery Do nothing If the leakage is only very minimal and is not distressing then treatment is not necessarily needed. Pelvic floor exercises (PFE) The pelvic floor muscles run from the coccyx at the back to the pubic bone at the front and off to the sides. These muscles support your pelvic organs (uterus and bladder) and your bowel. Any muscle in the body needs exercise to keep it strong so that it functions properly. This is more important if that muscle has been damaged. PFE can strengthen the pelvic floor and correct or reduce stress incontinence. PFE are best taught by an expert who is usually a physiotherapist. These exercises have little or no risk and even if surgery is required at a later date, they will help your overall chance of becoming continent. Devices There are numerous devices (none on the NHS) which essentially aim to block the urethra. The devices are inserted either into the vagina or the urethra. They are not a cure but their aim is to keep you dry whilst in use, for example during keeping fit etc. A leaflet is available if you require further information. The benefits of stress incontinence surgery Around 80-90% women are substantially improved. This means you may get back to physical activity, such as running, dancing, gym etc. You can also resume sexual relations if these were hindered beforehand. We have been doing this operation from 2003 (compared to 1996 for TVT) so long term data is not available, but the information we have so far suggests that the outcome following TOT is similar to TVT. This also means you may have renewed confidence so, for example, you can go shopping etc. without fear of leaking, you do not have to worry about damp patches on clothing, and you do not have to worry about unpleasant odours. General risks of surgery Anaesthetic risk This is very small unless you have specific medical problems. This will be discussed with you. Haemorrhage There is a risk of bleeding with any operation. The risk from blood loss is reduced by knowing your blood group beforehand and then having blood available to give you if needed. It is rare that we have to transfuse patients after their operation. Infection There is a risk of infection at any of the wound sites. A significant infection is rare. The risk of infection is reduced by our policy of routinely giving antibiotics with major surgery. Page 2 of 8
Deep vein thrombosis (DVT) This is a clot in the deep veins of the leg. The overall risk is at most 4-5%, although the majority of these are without symptoms (1/10 to 1/100, i.e. common). Occasionally, this clot can migrate to the lungs which can be very serious and in rare circumstances it can be fatal (less than 1% of those who get a clot). DVT can occur more often with major operations around the pelvis and the risk increases with obesity, gross varicose veins, infection, immobility and other medical problems. The risk is significantly reduced by using special stockings and injections to thin the blood (heparin). Specific risks of this surgery The table below is designed to help you understand the risks associated with this type of surgery (based on the Royal College of Obstetricians and Gynaecologists Clinical Governance Advice - Presenting Information on Risk). Term Equivalent numerical ratio Colloquial equivalent Very common 1/1 to 1/10 A person in a family Common 1/10 to 1/100 A person in a street Uncommon 1/100 to 1/1000 A person in a village Rare 1/1000 to 1/10 000 Very rare Less than 1/10 000 A person in a small town A person in a large town Failure Around 10% (1/10 to 1/100, i.e. common) of women do not gain benefit from the operation. The operation, however, can be repeated. Voiding difficulty Approximately 10% of women (1/10 to 1/100, i.e. common) will have some difficulty in emptying their bladder in the short term and if this happens, we may send you home with a catheter for up to a week. If you still have difficulty emptying your bladder after 10 days (3%), then the options will be either learning how to catheterise yourself (you may need to do that few times a day after passing urine to get rid of any urine left behind in your bladder), or going back to theatre to have the tape cut. Once the tape is cut, you may re-develop incontinence but there is an option of having another tape at a later date. Some women may need to change position to satisfactorily empty their bladder. Bladder over activity Any operation around the bladder has the potential for making the bladder overactive (12% - 1/1 to 1/10, i.e. very common) leading to symptoms, such as urgency (needing to rush to the toilet) and frequency (needing to visit the toilet more often than normal). Tape exposure and extrusion The vaginal area over the tape may not heal properly or get infected and therefore part of the tape may need excising (10% - 1/10 to 1/100 i.e. common). This may need a return to theatre and may result in the operation being ineffective. Alternatively, an attempt to re-cover the tape can be made. Page 3 of 8
Very rarely the tape might erode into the urethra (urine pipe) or the bladder which would require an operation as well. The risk of exposure is increased by smoking and with certain diseases. Pain on intercourse This may arise from scar tissue in the vagina as a result of the incision. It is unusual but unpredictable. Visceral trauma During the sub-urethral sling operations the needle used may traumatise the bladder, or urethra (urine pipe). This is rare. If it is noticed after return from theatre to the ward it may necessitate going back to theatre for a general anaesthetic and an operation to repair the damaged organ. Leg or groin pain Occasionally, some patients describe pain in the groin or down the legs (less than 1% - 1/100 to 1/1000, i.e. uncommon). The short-term results seem comparable to operations like the TVT, but the longterm results are unknown. The tape material used is similar to TVT. How is the operation performed? The operation can be performed under spinal or general anaesthetic as described above. Special needles are used. The exit point for these needles is the groin see figures 2 and 3. There will therefore be a small incision in each groin as well as the incision in the vagina. These incisions will have a suture in after the operation. Figure 2 Insertion of transobturator tape (TOT) (Images courtesy of American Medical Systems, Inc.) The operation: Transobturator tape (TOT or TVT-O) Facts and figures This is a recently developed operation and therefore less operations overall have been performed. The main advantage, however, is that the procedure is performed through a less risky operative field. Page 4 of 8
Figure 3 Insertion of transobturator tape (TVT-O) (Images courtesy of Ethicon) An alternative operation to the TOT: Tension free vaginal tape (TVT) This operation involves inserting a synthetic tape through the vagina in order to sit like a hammock under the urethra (urine pipe) and prevent it moving down when the intra-abdominal pressure increases such as when coughing. It now has data to show that it gives comparable success rate to the above traditional operation (colposuspension) up to 17 years after the operation, whilst allowing patients to go home on the same day in most cases. Its main drawback is a small risk of injury to the bladder, urethra or bowels, and an extremely rare risk of damage to a major blood vessel which has resulted in a few deaths (out of more than a million procedures). There is a small risk of voiding difficulty and a small risk of overactive bladder symptoms (urgency and frequency). As with the TOT, it can cause tape erosion and difficulty emptying the bladder (explained above). After the operation (postoperative care) After the operation you will be taken back to the ward, where the nurses will check your blood pressure, pulse and wound. You may eat and drink immediately on return from theatre. A mild pain killer may be required. Page 5 of 8
Most women do not have a catheter and can go home once they have urinated satisfactorily and had a bladder scan to ensure the bladder is empty. Some women will return from theatre with a urethral catheter to drain the bladder. Once this is removed and they have emptied their bladder satisfactorily they can go home. You may be given injections to keep your blood thin and reduce the risk of blood clots normally once a day until you go home or longer in some cases. The wound is not normally very painful but sometimes you may require tablets or injections for pain relief. There will be slight vaginal bleeding like the end of a period after the operation. This may last for a few weeks. At home after the operation It is important to avoid straining, particularly in the first weeks after surgery. Therefore, avoid constipation and heavy lifting. After any operation you will feel tired and it is important to rest. It is also important not to take to your bed. Mobilisation is very important. Simply pottering around the house will use your leg muscles and reduce the risk of clots in the back of the legs (DVT) which can be very dangerous. Activity will also help to get air into your lungs and reduce infections. You can do pelvic floor exercises but build these up very gently. If you do too much it will be uncomfortable. It is advisable to have showers rather than baths for 3 weeks and to keep puncture wounds clean and dry. They heal in about 5 days. Avoid constipation by: Drinking plenty of water/juice. Eating fruit and green vegetables, especially broccoli. Eating plenty of roughage e.g. bran/oats. Do not use tampons, have intercourse or swim for 6 weeks, otherwise you put yourself at risk of the tape eroding into the vagina. There are stitches in the skin wound in the vagina. The surface knots of the stitches may appear on your underwear or pads after about 2 weeks; this is quite normal. There may be little bleeding again after about 2 weeks when the surface knots fall off, but this is nothing to worry about. There are also stitches in the groin. At 2 weeks gradually build up your level of activity. After 4-6 weeks, you should be able to return completely to your usual level of activity. You should be able to return to a light job after about 3-4 weeks. Leave a very heavy or busy job until 6 weeks. Page 6 of 8
You can drive as soon as you can make an emergency stop without discomfort, generally after 2 weeks, but you must check this with your insurance company, as some of them insist that you should wait for 6 weeks. What the Medicines and Healthcare Products Regulatory Agency suggest In response to reported adverse events and concerns about mesh products, the Medicines and Healthcare Products Regulatory Agency (MHRA), on behalf of the Department of Health (DH), commissioned a review of evidence related to most frequent adverse events. The risks quoted in this leaflet are based on the MHRA report. It is now mandatory that any complications related to mesh are reported to the MHRA. In addition, the MHRA have published a list of questions patients should discuss with their surgeon before proceeding with the surgery, listed below: Why have you chosen the use of surgical tape or a traditional non-tape repair in my particular case? What are the alternatives? What are the chances of success with the use of tape versus use of other procedures such as traditional surgery? What are the pros and cons of using tape including associated side-effects and what are the pros and cons of alternative procedures? What sexual problems may be encountered with use of tape and traditional surgery and/or other procedures? If tape is to be used, what experience have you had with implanting these devices? What have been the outcomes from the people whom you have treated? What has been your experience in dealing with any complications that might occur? What if the tape does not correct my problems? What other treatments are available? What can I expect to feel after surgery and for how long? If I have a complication related to the tape, can the tape be removed and what are the consequences associated with this? Further information Bladder & Bowel UK http://www.bladderandboweluk.co.uk/ Telephone: 0161 607 8219 Things I need to know before I have my operation Please list below any questions you may have, having read this leaflet.. Page 7 of 8
Please describe what your expectations are from surgery To be completed by the Communications office Leaflet code: PIL201803-02-SITT Created: January 2017 / Revised: March 2018 / Review Date: March 2020 Further sources of information NHS Choices: www.nhs.uk/conditions Our website: www.sfh-tr.nhs.uk Patient Experience Team (PET) PET is available to help with any of your compliments, concerns or complaints, and will ensure a prompt and efficient service. King s Mill Hospital: 01623 672222 Newark Hospital: 01636 685692 Email: sfh-tr.pet@nhs.net If you would like this information in an alternative format, for example large print or easy read, or if you need help with communicating with us, for example because you use British Sign Language, please let us know. You can call the Patient Experience Team on 01623 672222 or email sfh-tr.pet@nhs.net. This document is intended for information purposes only and should not replace advice that your relevant health professional would give you. External websites may be referred to in specific cases. Any external websites are provided for your information and convenience. We cannot accept responsibility for the information found on them. If you require a full list of references for this leaflet, please email sfh-tr.patientinformation@nhs.net or telephone 01623 622515, extension 6927. Page 8 of 8